Single-Tablet HIV Treatment Deemed Safe, Effective

Single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide is safe and effective among adults with virologically suppressed human immunodeficiency virus-1 (HIV-1) infection, according to a recent study.

Findings were presented at ID Week, which took place from October 4 to 8, 2017, in San Diego, California.
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Simplified treatment regimens with reduced pill burden and fewer adverse effects are likely beneficial for HIV patients.

For their study, the researchers evaluated 1141 patients at 106 sites across 9 countries in North America and Europe from April 1, 2015, to February 24, 2017. Adults with HIV-1 who were treatment-experienced, were virologically suppressed, and had a history of virological failure on non-darunavir regimens were eligible to participate. Virological suppression was defined as a viral load of less than 50 copies per mL for 2 months or more (1 viral load of 50-200 copies per mL was allowed within 12 months prior to screening).

Patients were randomly assigned to either switch to a once-daily tablet containing 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine, and 10 mg tenofovir alafenamide (n = 763) or to continue their current regimen (n = 378). Follow-up lasted 48 weeks.

The primary outcome included the cumulative, 48-week proportion of participants with virological rebound, defined as a confirmed viral load of 50 copies per mL or more; or premature discontinuations, with a last viral load of 50 copies per mL. Non-inferiority of the study regimen vs the control regimen was tested in the intention-to-treat population and was calculated with a 4% margin.

Results indicated that the study regimen was non-inferior to the control regimen for virological rebound over the course of 48 weeks (efficacious in 2.5% vs 2.1% of patients, respectively). The researchers did not observe resistance to any study drug. The proportion of treatment discontinuations (1% vs 1% of patients, respectively) and grade 3 to 4 adverse events (7% vs 8% of patients, respectively) were similar between the study and control groups.

The researchers noted a small, statistically significant difference between groups in change from baseline in the ratio of total cholesterol to high-density lipoprotein cholesterol. One serious adverse event of pancreatitis in the study group was found to be potentially related to the study regimen.

“Our findings show the safety and efficacy of single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide as a potential switch option for the treatment of HIV-1 infection in adults with viral suppression,” the researchers concluded.

Reference:

Orkin C, Molina JM, Negredo E, et al; the EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial [Published online October 6, 2017]. Lancet HIV. http://dx.doi.org/10.1016/S2352-3018(17)30179-0.